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NCT ID: NCT02235649 Completed - Focus of Study Clinical Trials

Exploring the Feasibility of Social Skills Training in People With Psychosis

Start date: March 2014
Phase: N/A
Study type: Interventional

Reduced social and community functioning is a predominant and enduring feature in people experiencing severe mental illness such as psychosis. The large majority of interventions (mostly pharmacological) target the so called positive symptoms (e.g. hallucinations and delusions) but poorly address functional and social consequences of the illness. This study attempts to fill this gap by assessing the feasibility and acceptability of a psychological intervention targeting social cognition deficit in people with psychosis. The intervention is a group psychological treatment facilitated by a clinical psychologist targeting competencies such as emotion recognition, social situation appraisal and guessing people's intentions and mental states. The group therapy takes advantage of audiovisual material to illustrate strategies and thinking styles that may help participants to overcome difficulties in social settings. A second objective of this study is to test a new method to measure social cognition. Recent research showed that interview and performance based tests are poorly associated with every day activity of people with schizophrenia. This study is planning to evaluate the feasibility of new assessment methods for social cognition in everyday life using portable electronic devices (Experience Sampling Method and an activity watch). These devices will be carried by participants in their everyday life and will ask about feelings and levels of social activities at random times and record basic physiological and activity levels.

NCT ID: NCT02235181 Completed - Clinical trials for Twin Pregnancy With Antenatal Problem

An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

STOPPIT-2
Start date: November 1, 2014
Phase: N/A
Study type: Interventional

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

NCT ID: NCT02234843 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

EINSTEIN Jr
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

NCT ID: NCT02234648 Completed - Hypertension Clinical Trials

To Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.

Start date: August 2014
Phase: N/A
Study type: Interventional

Given the global health issues associated with poor cardiovascular function, interventions that help reduce the severity, with emphasis on prevention would not only have economic implications, but would also improve health, wellbeing and quality of life. Research provides evidence that consumption of a diet high in plant foods and rich is polyphenols is associated with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999; Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006) and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining of blood vessels (endothelial dysfunction) has been linked to increased risk of cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency Cherry Juice and their efficacy with respect to vascular function has not been fully determined. This study will examine the influence of tart Montmorency cherry juice on cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood flow in the microcirculation by laser Doppler imaging. This study will also examine digital volume pulse and pulse wave analysis. These data will provide information on the ability of TMCJ to affect blood flow and vascular function.

NCT ID: NCT02234583 Completed - Clinical trials for Pain Associated With Fibromyalgia

An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

Start date: February 4, 2015
Phase: Phase 3
Study type: Interventional

This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.

NCT ID: NCT02234323 Completed - Hemophilia A Clinical Trials

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

Start date: January 12, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

NCT ID: NCT02234310 Completed - Hemophilia B Clinical Trials

Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

PUPs B-LONG
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.

NCT ID: NCT02234141 Completed - Clinical trials for Pulmonary Arterial Hypertension

Selonsertib in Adults With Pulmonary Arterial Hypertension

ARROW
Start date: November 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.

NCT ID: NCT02234050 Completed - Clinical trials for Recurrent High Grade Meningioma

Trabectedin for Recurrent Grade II/III Meningioma

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

NCT ID: NCT02233699 Completed - Clinical trials for Chronic Idiopathic Cough

A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough. The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester Cough Questionnaire (LCQ) will be evaluated.